Recruiting at 5 sites Phase 1 Advanced Solid Tumor

Clinical trial for Advanced Solid Tumor

Official title M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors

ClinicalTrials.gov ID: NCT07166601

What this study is testing

What is M0324?

M0324 is an investigational biological medicine being studied as a potential treatment for advanced solid tumors.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The study aims to find the safest and most effective dose of M0324 and to see if it shows early signs of working against cancer.
Who it's for
It is looking for adults who have advanced solid tumors that have not responded to other treatments.
What's involved
Participants will receive M0324 by itself, or with the drug pembrolizumab, or with a chemotherapy mix called mFOLFIRINOX, and will have regular medical visits and tests to monitor safety and drug levels.
Time commitment
The study lasts several months, with multiple scheduled visits for drug administration and monitoring.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Participants with previously untreated metastatic pancreatic ductal adenocarcinoma, who are judged by Investigator as eligible for treatment with...
  • Other protocol defined could apply.

You likely can't join if

  • Has a history of chronic diarrhea greater than or equal to (\>=) Grade 2, inflammatory disease of the colon or rectum, or unresolved partial or...
  • Participant has a history of malignancy within 3 years before the date of enrollment
  • Uncontrolled or poorly controlled arterial hypertension, uncontrolled cardiac arrhythmia, unstable angina, myocardial infarction, congestive heart...
  • Life expectancy of less than 3 months
  • Other protocol defined exclusion criteria could apply.

The study team makes the final eligibility decision.

Where it is enrolling

  • New Haven, Connecticut, United States
  • New York, New York, United States
  • San Antonio, Texas, United States
  • Toronto, Canada
  • Chūōku, Japan

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at New Haven, Connecticut, United States; New York, New York, United States; San Antonio, Texas, United States; Toronto, Canada; Chūōku, Japan. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.